EU Regulatory Procedures Strategic Choices

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1 TOPRA Module 1 EU Regulatory Procedures Strategic Choices A presentation by Connie van Oers, Managing Consultant, Xendo BV ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

2 Learning Outcomes Knowledge of EU regulatory procedures; Basics of Mutual Recognition (MRP) and Decentralised Procedure (DCP); Basics of Centralised Procedure (CP); Understanding factors influencing the choice of a regulatory procedure;

3 In This presentation we will cover Legal Basis for a Marketing Authorisation Application Principles MRP/DCP procedure; Role of Reference Member State; Centralised Procedure; Mandatory and optional scope of centralised procedure Role of Rapporteur; Special circumstances; Strategic Choices

4 A Marketing Authorisation A license to sell a medicine License granted by Competent Authorities Assessment is benefit/risk based on: Quality Safety Efficacy Positive risk-benefit balance in favour of patients and users of products once they reach the market place

5 How to obtain a marketing Authorisation National Application in individual countries MRP/DCP National application intended for more than one country Mutual recognition Decentralised procedure Centralised Procedure 1 marketing authorisation 1 (invented) name 1 common product information

6 Legal Basis Article 8(3) Full Application Full dossier; quality, nonclinical and clinical data Article 10 (1) Generic Reference product on the market no less than 8 years Same qualitative, quantitative compositions Same pharmaceutical form Bioequivalence

7 Legal Basis Article 10 (3) Hybrid (mixed) Application Additional non-clinical/clinical data in case: Product does not meet definition of generic No bioequivalence in case of changes in the active substance(s), Change to active substance, therapeutic indications, strength, pharmaceutical form or route of administration Article 10 (4) Biosimilars Additional non-clinical/clinical data required in case of: product does not meet definition of generic, esp. differences relating to raw materials or differences in manufacturing processes of biological product and reference biological product

8 Legal Basis Article 10(a) Well established use Well-established medicinal use of active substance for at least 10 years Non-clinical and clinical trial results replaced by appropriate scientific literature Article 10(b) Fixed combination products Active substances used in composition of authorised medicinal products but not in combination New non-clinical and clinical data relating to the combination are required Article 10 (c) Informed consent / Duplicate MAH allows reference to data on file to support assessment of other medicinal products with same qualitative and quantitative composition of active substance and same pharmaceutical form

9 How to obtain a marketing Authorisation - procedures National Application in individual countries MRP/DCP National application intended for more than one country Mutual recognition Decentralised procedure Centralised Procedure 1 marketing authorisation 1 (invented) name 1 common product information

10 Competent Authorities National Health Authorities in each Member State The European Medicines Agency Partners national competent authorities

11 Nationale Procedure Until 1998 Currently only for: Marketing authorisation in a single EU Member State (No MA in any other Member State and no pending application in a Member State) National phase Mutual Recognition Procedure Timelines: national Result: National approval, national SPC (difference between Member States)

12 Mutual Recognition (MRP) Decentralised procedure Principle of Mutual Recognition/ Decentralised procedure Relying upon principle of mutual recognition A Marketing authorisation in one Member State ought in principle to be recognised by the authorities of other member States. As opposed to CHMP opinion by majority of votes (CP) As opposed to every HA doing their own procedure, assessment (National)

13 MRP and DCP Mutual Recognition procedure (MRP) Where the medicinal product has already received in a MS a MA at the time of application Decentralised Procedure (DCP) Where the medicinal product has not received in a MS a MA at the time of application

14 Eligibility Applications for MA in more than one Member State Open for all applications not falling under mandatory scope of Centralised procedure: New active substances; Generic medicinal products; Informed consent applications; Bibliographic applications; Known substances in new combinations; Line extensions; Herbal medicinal products; Homeopathic products Flexible - choice of MSs, with different trade names and MA holder Possibility of repeating procedure Applicant to choose RMS 14

15 Overview of MRP and DCP MRP National registration in RMS (Updated) Assessment Report Dossier submission to CMS Validation (14 days) 90 Day assessment DCP Submission to RMS and CMS Validation (14 days) Assessment I 120 days Assessment II 90 days Discussion at CMDh (if necessary) Discussion at CMDh (if necessary) 90 days 210 days National phase National phase

16 Timelines MRP 210 Days - National Registration 90 Days preparation AR Day 0 Day 50 Day 60 Day 75 Day 85 Day 90 Start procedure - CMS Comments - Applicants s Response - CMS Comments - Final CMSs position - Consensus/close of procedure

17 Timelines DCP Assessment I Day 0 Start procedure Day 70 - Preliminary AR Day CMS send comments/questions Day Clockstop Day Applicants responses Day Consensus/ close of procedure - No Consensus/ AR to applicant Assessment II Day RMS + CMS comments to Applicant Day Applicant Responses Day Consensus/Close of Procedure Day Break-out session if required Day Resolution of any minor outstanding comments Day Consensus/Close of Procedure

18 Role of Reference Member State Regulatory Advisor to Applicant Scientific Assessor of Dossier Moderator between Applicant and CMS Reference Member State 18

19 Role of RMS CMS CMS Provide regulatory and scientific advice CMS RMS CMS Decides timetable Scientific assessment assessment report Evaluation responses Central point between applicant and CMS CMS CMS Organises and chairs break-out sessions, instruct applicant Applicant Refers to CMDh Informs EMA if after referral no consensus Informs applicant and CMS after positive conclusion and prepares final assessment report Public assessment report

20 Choosing RMS and CMSs Based on regulatory, strategic and commercial reasons Availability of RMS in DCP Were they supportive of product/dossier during scientific advice Expertise of RMS for certain type of product Availability of slot For MRP, RMS is where dossier was filed and approved nationally 20

21 Referral Automatic in the absence of consensus Aim is to resolve PSRPH which have not been resolved during the procedure, and must be explained in detail Applicant cannot ask for a referral to appeal a negative consensus Written response is always necessary, oral hearing possible No new data can be submitted, elaboration or clarification of existing data is acceptable CMS not included in the DCP/MRP will be involved in the discussions but not the formal agreement If agreement is not reached move to CHMP Referral EMA MSs agreeing with AR at Day 60 proceed to national phase 21

22 Withdrawal MRP At any time Except after a PSRPH has been raised If PSRPH is dealt with by CMDh or if failed in an arbitration procedure in the CHMP an opinion will be given After withdrawal automatic referral to CMDh DCP At any time Except during assessment Step II, once PSRPH has been raised, If PSRPH is dealt with by CMDh or if failed in an arbitration procedure in the CHMP an opinion will be given Withdrawal after day 120 automatic referral to CMDh 22

23 Repeat-use MRP To include further CMSs All ongoing procedures (e.g. variations and renewals) to be finalised and dossier updated Dossier update to include Responses to previous procedures; variations/renewals Commitments fulfilled without a variation procedure Additional data to comply with recent regulatory requirements, e.g. Risk Management Plan, Environmental Risk Assessment. These must be added by variation Formatting to CTD structure if dossier is in old EU format Consider conducting new studies according to current standards, or provide updated evaluation of risk-benefit Discuss issue with RMS before submission of RU-MRP 23

24 Centralised Procedure

25 The European Medicines Agency Protection and Promotion of Public and Animal Health Evaluation and supervision of medicines Marketing Authorisations Responsible for the scientific evaluation of applications for medicines in the centralised procedure EU's safety-monitoring or 'pharmacovigilance' system Referrals Coordinating inspections: GMP, GCP, GLP, PhV Stimulating Innovation and research Scientific advice, Guidelines, SME office, Orphan designation, Innovation Task Force

26 CHMP Scientific Committee EMA Composition Chair (Tomas Salmonson, Sweden) One member and alternate from 28 member states One member and alternate from Iceland and Norway Up to five co-opted members to provide additional expertise 3 year mandate renewable

27 CHMP Tasks Scientific advice Preparation of opinion of EMA on questions relating to the evaluation of medicinal product for human use Initial assessment Post-authorisation and maintenance (variations) Urgent opinions (pharmacovigilance, Serious concerns on public health, Quality defects, Urgent Safety Restriction) European Public Assessment Report

28 Centralised Procedure: Mandatory and optional scope Legal Basis: Regulation (EC) No 726/2004, Article 3 (references to Annex) Mandatory Scope: Art 3(1) Optional Scope: Art 3 (2)

29 Mandatory scope of CP Biopharmaceuticals recombinant DNA technlogy Controlled expression of genes coding for biologically active proteins Hybridoma and monoclonal antibody cells biosimilars

30 Mandatory Scope of CP Advanced Therapy Medicinal Products (ATMPs) Gene therapy medicinal products Somatic cell therapy medicinal products Tissue engineered products Certain therapeutic areas Aids, Cancer, Neurodegenerative disorders, Diabetes, Autoimmune diseases, Viral diseases Orphan medicinal products

31 Optional Scope of CP New active substances (outside mandatory scope indications) A new chemical, biological or radiopharmaceutical active substance, as defined in Annex III to Chapter 1 of Notice to Applicants, includes: A chemical, biological or radiopharmaceutical substance not previously authorised as a medicinal product in the European Union

32 Steps to obtain an EU marketing Authorisation Submission of eligibility request between 18 to 7 months before submission Notification of intention to submit an application 7 months before submission Appointment of Rapporteurs 7 months before submission Pre-submission Meeting 7 months before submission Submission of Application Scientific evaluation 210 days of assessment CHMP scientific opinion European Commission decision 32

33 Role of the Rapporteur Spokesperson of the CHMP Assessment Report Can be important for the applicant Good and open relationship is important

34 Rapporteur/co-Rapporteur appointment Appointment from CHMP members Expert team Appointment normally in accordance with expertise (therapeutic area) Supported by their national experts Applicant s proposal/preferences are not considered o ATMPs: (Co-)Rapporteurs appointed amongst CAT Members o PRAC Rapporteur and Co-Rapporteur appointed

35 EMA Product Team Product Team Leader (PTL) and Product Team Members Nominated by EMA Responsible for handling procedural aspects Both pre- and post- authorisation Phase PTL primary contact point for the applicant Liaison between EMA, (Co-) Rapporteur, Applicant 35

36 Centrale Procedure - Timelines Day 1 Day 80 Day 120 Day 121 Day 157 Day 180 Day 181 Clockstop Start Procedure Preliminary Assessment Report List of questions - Submission responses Joint Assessment Report CHMP discussion Restart of the clock and oral explanation Day Day Preparation final product information CHMP opinion 36

37 Potential options Accelerated review Exceptional circumstances Conditional approval Orphan drugs Options for Small and medium sized enterpises (SME)

38 Accelerated assessment Request before submission, at least 10 working days before submission Reduced timeline from 210 to 150 days Major Public Health Interest particularly from the point of view of therapeutic innovation Justification of public health interest, case-by-case Unmet need, new methods of therapy, improves on existing methods If at day 120 or 150 CHMP or applicant consider accelerated assessment no longer appropriate, assessment may continue under standard timelines

39 Conditional Approval Extensive studies/data may not be required in case of: Seriously debilitating/ life-threatening diseases Emergency products for Public Health threats Orphans Requirements: Positive benefit/risk balance Unmet medical need Possibility to provide comprehensive data Benefit to public health outweighs the risks of placing on market without comprehensive studies Prerequisite: MA subject to specific obligations (to provide comprehensive data) 39

40 Exceptional Circumstances Applicant is unable to provide comprehensive data Indication so rare that no large phase III trial can be performed present state of scientific knowledge prohibits provision of comprehensive information Ethical concerns MA also subject to specific obligations Annual reassessment of risk-benefit Particular emphasis on safety of product Formal application to be submitted before MAA 40

41 Differences conditional approval and exceptional circumstances Conditional approval: - temporary authorisation with eventually a full dossier. - Valid for one year - can become normal marketing authorisation Approval under exceptional circumstances: - comprehensive development cannot/will not be provided - annual review - will not lead to normal marketing authorisation Only one legal basis can be chosen 41

42 Adaptive Licensing Prospectively planned, adaptive approach to bringing medicines to patients Timely patient access Providing adequate evolving information of benefit and risks Prospectively designed development plan, subject to early dialogue with stakeholders (authorities, patients, HTA) Unmet medical need Build on existing regulatory processes Pilot started in March

43 How to liaise options for dialogue Scientific advice - Early in development - can (and should) be repeated - national HA or EMA - combined with HTA Pre-submission meeting first opportunity to meet product team Clarification meeting - upon receipt of questions Oral explanation, SAG

44 44

45 45

46 Strategic choices Type of Application Mandatory scope of Centralised Procedure Legal Basis Complete Biobliographic generic

47 Strategic Choices Market considerations Where will the product be marketed? All EU member states Limited number of countries Expand later: repeat use MRP Decentralised Procedure to target main markets. Repeat Mutual Recognition procedure(s) to add new Member States as required Capability of the organisation Ability to market throughout EU CP more efficient to market in all or majority of MS Existing license in one MS Mutual Recognition Procedure

48 Strategic choices fees Centralised Procedure One fee Mutual Recognition, Decentralised procdure Fee per member state Fee RMS, Fee CMS

49 Strategic choices Fees Applications for which a full dossier needs to be submitted in CP 49

50 Strategic Choices Timelines Is there a faster procedure? MRP: national plus 90 days national timelines in MRP not defined DCP: 210 days Centralised Procedure: 210 days Accelerated assessment: from 210 to 150 days

51 Strategic Choices Procedure Is there an easier procedure? only data count withdrawal of a MS in MRP/DCP withdrawal or negative opinion in CP

52 Choice of names Centralised Procedure one single name MRP/DCP names can be different in MS name flexibility

53 Strategic Choices Special cases Conditional approval Exceptional circumstances Not to be mistaken for an easier option when in fact data are deficient Need sufficient data for positive risk/benefit Conditional approval: condition imposed should be able to be met

54 Strategic choices Rapporteur Reference Member State Centralised Procedure MRP/DCP Applicant can not choose rapporteur choose based on scientific expertise availability supportive of your product (during scientific advice) Should you try to influence the choice of the Rapporteur?

55 In This presentation we covered Knowledge of EU regulatory procedures; Basics of Mutual Recognition (MRP) and Decentralised Procedure (DCP); Basics of Centralised Procedure (CP); Understanding factors influencing the choice of a regulatory procedure;

56 Recommended references ec.europa.eu/health/documents/eudralex/

57 QUESTIONS?

58 Contact details Name: Connie van Oers, Managing Consultant, Xendo BV Tel: +31 (0)

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